Once-Daily Atomoxetine Treatment for Children and Adolescents With Attention Deficit Hyperactivity Disorder: A Randomized, Placebo-Controlled Study

Michelson, David; Allen, Albert J.; Busner, Joan; Casat, Charles; Dunn, David; Kratochvil, Christopher; Newcorn, Jeffrey; Sallee, F. Randy; Sangal, R. Bart; Saylor, Keith; West, Scott; Kelsey, Douglas; Wernicke, Joachim; Trapp, Nancy J.; Harder, Donald

doi:10.1176/appi.ajp.159.11.1896

Cited by 599Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesDevelopmental and Educational Neuropsychology

Once-Daily Atomoxetine Treatment for Children and Adolescents With Attention Deficit Hyperactivity Disorder: A Randomized, Placebo-Controlled Study

Michelson, David, Allen, Albert J., Busner, Joan, Casat, Charles, Dunn, David, Kratochvil, Christopher, Newcorn, Jeffrey, Sallee, F. Randy +7 more·2002·American Journal of Psychiatry

DOI 10.1176/appi.ajp.159.11.1896

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Abstract

OBJECTIVE: The authors assessed the efficacy of once-daily atomoxetine administration in the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD). METHOD: In a double-blind study, children and adolescents with ADHD (N=171, age range=6-16 years) were randomly assigned to receive 6 weeks of treatment with either atomoxetine (administered once daily) or placebo. RESULTS: Outcomes among atomoxetine-treated patients were superior to those of the placebo treatment group as assessed by investigator, parent, and teacher ratings. The treatment effect size (0.71) was similar to those observed in previous atomoxetine studies that used twice-daily dosing. Parent diary ratings suggested that drug-specific effects were sustained late in the day. Discontinuations due to adverse events were low (less than 3%) for both treatment groups, and no serious safety concerns were observed. CONCLUSIONS: Once-daily administration of atomoxetine is an effective treatment for children and adolescents with ADHD.

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Atomoxetine, extended-release guanfacine, and extended-release clonidine have demonstrated efficacy in reducing core symptoms among school-aged children and adolescents.
“Among nonstimulant medications, 1 selective norepinephrine reuptake inhibitor, atomoxetine,99,100 and 2 selective α-2 adrenergic agonists, extended-release guanfacine101,102 and extended-release clonidine,103 have also demonstrated efficacy in reducing core symptoms among school-aged children and adolescents”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [100]
Both therapies displayed safety profiles consistent with findings from previous studies.
“Both therapies displayed safety profiles consistent with findings from previous studies [9, 11–13, 28–30].”
From Efficacy and Safety of Lisdexamfetamine Dimesylate and Atomoxetine in the Treatment of Attention-Deficit/Hyperactivity Disorder: a Head-to-Head, Randomized, Double-Blind, Phase IIIb Study (2013) · cites this paper as [29]
The most frequently reported TEAEs in the LDX treatment group (decreased appetite, decreased weight, headache, nausea and insomnia) and in patients receiving ATX (headache, nausea, somnolence, decreased appetite and fatigue) are consistent with findings from previous studies.
“The most frequently reported TEAEs in the LDX treatment group (decreased appetite, decreased weight, headache, nausea and insomnia) and in patients receiving ATX (headache, nausea, somnolence, decreased appetite and fatigue) are consistent with findings from previous studies [9, 11–13, 28–30].”
From Efficacy and Safety of Lisdexamfetamine Dimesylate and Atomoxetine in the Treatment of Attention-Deficit/Hyperactivity Disorder: a Head-to-Head, Randomized, Double-Blind, Phase IIIb Study (2013) · cites this paper as [29]
Optimal efficacy of atomoxetine requires 4-6 weeks of treatment.
“This time period may not be adequate as optimal efficacy of atomoxetine requires 4-6 weeks of treatment [40].”
From Comparative efficacy and acceptability of methylphenidate and atomoxetine in treatment of attention deficit hyperactivity disorder in children and adolescents: a meta-analysis (2011) · cites this paper as [40]

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Authors: Michelson, D., Allen, A. J., Busner, J., Casat, C., Dunn, D., Kratochvil, C., Newcorn, J., Sallee, F. R., Sangal, R. B., Saylor, K., West, S., Kelsey, D., Wernicke, J., Trapp, N. J., & Harder, D.
Affiliations: Eli Lilly (United States) (US)
ORCID: Michelson, David
Kratochvil, Christopher
Newcorn, Jeffrey
Sangal, R. Bart
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2002-11-01
Volume: 159
Issue: 11
Pages: 1896-1901
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/appi.ajp.159.11.1896
OpenAlex: W2123980944
Cited by: 599
References: 12
Citations by year: 2026: 4 · 2025: 10 · 2024: 8 · 2023: 6 · 2022: 9 · 2021: 9 · 2020: 8 · 2019: 4 · 2018: 8 · 2017: 14 · 2016: 27 · 2015: 24 · 2014: 22 · 2013: 26 · 2012: 24
FWCI: 24.80
Type: journal article
Language: en
Open access: closed
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Social Sciences › Psychology › Neuropsychology and Physiological Psychology › Developmental and Educational Neuropsychology
Keywords: atomoxetine, attention deficit hyperactivity disorder, once-daily dosing, children and adolescents, ADHD medication, treatment efficacy, adverse events, parent ratings, teacher ratings
MeSH terms: Atomoxetine Hydrochloride, Adolescent, Antidepressive Agents, Attention Deficit Disorder with Hyperactivity, Child, Drug Administration Schedule, Female, Humans, Male, Personality Assessment, Propylamines, Treatment Outcome

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Once-Daily Atomoxetine Treatment for Children and Adolescents With Attention Deficit Hyperactivity Disorder: A Randomized, Placebo-Controlled Study

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